Design And Evaluation Of Multiparticulate Systems Prepared Using Sieving-Spheronisation And Extrusion-Spheronisation
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Date
2011-03
Authors
Karim, Sabiha
Journal Title
Journal ISSN
Volume Title
Publisher
Universiti Sains Malaysia
Abstract
Pelletised dosage forms can be prepared by different methods which, in general,
are time consuming and labor intensive. The current study was carried out to assess the
feasibility of preparing spherical pellets by sieving the wet powder mass followed by
spheronisation. This method was compared with extrusion-spheronisation process in
terms of physical characteristics and in-vitro dissolution profile of the developed
formulations. The fast release paracetamol pellets were comprised of, microcrystalline
cellulose, lactose, crospovidone and polyvinyl pyrrolidone-K90. The percentage yield of
paracetamol pellets produced by sieving-spheronisation was higher (p<0.05) in
comparison with that produced by extrusion-spheronisation. The extrusionspheronisation
showed better flowability (p<0.05) than sieving-spheronisation. However,
no significant difference was found in other physical properties of two methods. The
dissolution profile was slightly higher in sieving-spheronisation technique, the similarity
factors showed that dissolution profiles can be considered comparable in the
formulations prepared by two methods and followed first order kinetics. The rate of drug
release was essentially independent of pH and agitation rate. Omeprazole spherical
pellets with required release rate were developed using sieving-spheronisation process.
Pellets with desired characteristics were obtained with minimum amount of
microcrystalline cellulose (16%), lactose, polyvinylpyrrolidone K30, polyethylene
glycol 6000 and sodium lauryl sulfate. Pellets prepared by sieving-spheronisation
showed significantly higher (p<0.05) percentage yield as compared to that of extrusionspheronisation.
Omeprazole delay release system was developed by Kollicoat 30DP,
using bottom spray fluidised bed system. Coating level of 17.5 % prevented the drug
release less than 10% at pH 1 for initial 2 hours and at pH 6.8 release was 80 to 84%
within 45 minutes, following the first order release kinetics. In accelerated stability
studies, both drugs followed the zero order degradation.
Description
Keywords
Feasibility of preparing spherical pellets , wet powder mass followed by spheronisation